UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018507 |
|---|---|
| Receipt number | R000021421 |
| Scientific Title | Randomized control study comparing quality of life after single-port versus conventional video-assisted thoracoscopic surgery for lung cancer |
| Date of disclosure of the study information | 2015/07/31 |
| Last modified on | 2015/08/04 15:46:27 |
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Basic information
Public title
Randomized control study comparing quality of life after single-port versus conventional video-assisted thoracoscopic surgery for lung cancer
Acronym
RCT of single-port versus conventional VATS for lung cancer
Scientific Title
Randomized control study comparing quality of life after single-port versus conventional video-assisted thoracoscopic surgery for lung cancer
Scientific Title:Acronym
RCT of single-port versus conventional VATS for lung cancer
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Compariosn of post operative pain and QOL between single incision and conventional VATS
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
post operative pain(Numeric Rating Scale)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
single port
Interventions/Control_2
conventional
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
c-stage I primary lung cancer
Key exclusion criteria
multiple organ cancer
low cardiopumonary reserve,
impossible one lung ventilation
BMI>35
pregnancy
psychiatric disorder
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shin-ichi Yamashita |
Organization
Fukuoka University Hospital
Division name
Department of General Thoracic surgery
Zip code
Address
7-45-1, Nanakuma,Jonanku, Fukuoka, Japan
TEL
092-801-1011
yamashi1@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shin-ichi Yamashita |
Organization
Fukuoka University Hospital
Division name
Department of General Thoracic surgery
Zip code
Address
7-45-1, Nanakuma,Jonanku, Fukuoka, Japan
TEL
092-801-1011
Homepage URL
http://www.med.fukuoka-u.ac.jp/thoracic/index.html
yamashi1@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University Hospital
Department of General Thoracic surgery
Institute
Department
Personal name
Funding Source
Organization
Fukuoka University Hospital
Department of General Thoracic surgery
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
福岡大学病院呼吸器・乳腺内分泌・小児外科
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 31 | Day |
Related information
URL releasing protocol
http://www.med.fukuoka-u.ac.jp/thoracic/index.html
Publication of results
Unpublished
Result
URL related to results and publications
http://www.med.fukuoka-u.ac.jp/thoracic/index.html
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2015 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 31 | Day |
Last modified on
| 2015 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021421
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
